EMA virtual workshop on myocarditis post COVID-19 vaccination

On 16 January 2023, the EMA hosted a virtual workshop to review the current understanding of the epidemiology, clinical manifestation, and pathophysiology of myocarditis. This is an adverse event that can occur after immunisation with a mRNA COVID-19 vaccine (Spikevax and Comirnaty) or Nuvaxovid, a protein based-vaccine.

The insights and feedback gathered in the meeting are crucial input for a research agenda.

International regulators, academic researchers as well as the marketing authorisation holders for the two approved mRNA COVID-19 vaccines in the EU and for Nuvaxovid shared the available data generated so far and participated in the discussion.

The meeting was divided into two sessions:

• Session 1. Population-based studies and Clinical features of vaccine and infection induced myocarditis
• Session 2. Disease mechanism and molecular findings

Although a number of hypotheses regarding the pathophysiological mechanisms have been put forward, the research data available are extremely scarce and the actual mechanism for the pathogenesis of this adverse event post vaccination is far from being established.

A scientific document summarising the key aspects and the agreed steps to be taken to fill the gaps in the understanding of the aetiology of this disease will be published in due time.